The Food and Drugs Authority (FDA), has been caught in what is shaping out to be one of the most unwise decisions, since its establishment many years ago, by allowing a multinational medicines maker to test the efficacy of its vaccines for the deadly Ebola virus in the Hohoe Municipality of the Volta Region.
The state consumable and pharmaceutical regulator, confirmed this at a news conference on Monday, following fears expressed by the residents of Hohoe about an Ebola Research Centre set up in the town, where residents were being asked to volunteer for the experiment for a token of Gh¢200 and a mobile phone, per head.
The centre is led by one, Prof. Fred Binka, who is said to have received a juicy financial package from the multinational pharmaceutical giants, Crucell Holland B.V and Jassen Pharmaceutica (pty) Limited to carry out the trial for them.
The FDA revelation, has sent fears down the spine of many, especially those living around and its immediate environs. To many people, Hohoe in Ghana, unlike Guinea, Liberia, Sierra Leone or Democratic Republic of Congo (DRC), is not a high risk area.
The Herald, has learnt from insiders that, regional executives of the governing National Democratic Congress (NDC), who have taken up the matter, starting today, are deploying people not to volunteer themselves for the trials. From the foregoing The Herald suspects there could be a massive demonstrations against the Ministry of Health, FDA and others involved in the trials.
Ebola virus disease is a disease of humans and other primates caused by Ebola virus, was first discovered in Congo DR. Signs and symptoms start between two days and three weeks after contracting the virus. Symptoms include, fever, sore throat, muscular pain, and headaches. The disease kills between 25 and 90 out of every 100 persons, who get infected.
Ghana is yet to record an Ebola case. The argument has been that the FDA, should have sent the pharmaceutical company to unaffected areas in Guinea –Conakry, Liberia, Sierra Leone or the DRC, which have recorded millions of deaths to have the vaccines tested since they stand a higher risk of contracting the Virus.
The terrified Hohoe residents, had rushed to the regional executives of the NDC, complaining to the them about attempts to use them as “Guinea pigs” in an experiment to confirm whether or not the Ebola Vaccine could work.
In response to the fears expressed by the residents, the NDC regional officials, led by their chairman, Kwadwo Gyapong, Simon Amegashie-Viglo; the Regional Secretary and Henry Kojo Ametefee, the Regional Organiser, issued a press statement against the invitation of innocent Voltarians as volunteers for the Ebola Vaccine experiment.
In a seven-point statement, the NDC regional officers warned, “we are not going to sit down for our people to be used as guinea pigs in a needless experiment”.
They questioned, “why should a country that is not threatened by Ebola, risk the lives of its citizens for an unnecessary experiment?”
“We are appealing to the Minister of Health (MOH) to intervene and stop this experiment”, the statement said, adding, “we would be grateful if the experiment is cancelled completely to prevent the use of innocent Voltarians as guinea pigs”.
“We want to state that Ghana has no evidence of Ebola outbreak to warrant Ebola Vaccination trials. We have cases of malaria, cholera and HIV/AIDS among others. We need vaccines or remedies for these diseases”.
It, therefore, appealed to “all Voltarians to remain calm and should not risk their lives for GH¢200 and mobile phone”.
But the FDA in press statement sent to The Herald said “Ghana has joined other African countries in the global search for an effective vaccine against the deadly Ebola Virus Disease (EVD), which has claimed thousands of lives in Africa over the past few months”.
A statement signed by Hudu Mogtari, Chief Executive Officer (CEO) of the FDA claimed that, “the country now joins the UK, USA and 7 other African countries as places where these hugely important trials are taking place”.
“The Food and Drugs Authority (FDA) upon discussions with international partners and with support from its Expert Technical Advisory Committees, has granted approval for one trial which will test the safety and immunogenicity (indication of how the body will recognize and defend itself against substances that are foreign and harmful) of a potential anti-Ebola vaccine in one site in the country. The vaccine being tested has been produced by one of the world’s biggest pharmaceutical companies and the evaluation of the trial protocol included leading experts in Ghana, who are also considering a second application”.
It explained that “Ghana was selected because of its excellent infrastructure for clinical trials. As a Regional Centre of Regulatory Excellence (RCORE) for Clinical Trials Oversight in Africa as designated by New Partnership for Africa’s Development (NEPAD)/Africa Medicines Regulatory Harmonization (AMRH), the FDA has joined experts from US-FDA, European Medicines Agency, Health Canada and the WHO to provide the technical support in the evaluation of Ebola vaccine clinical trials for other affected countries”.
The FDA, in considering these applications, is mindful of its public health protection role in Ghana as well as its overall contribution to global health.
It insisted “these trials are being conducted to the highest ethical standards as operates globally and the FDA is satisfied that all measures to ensure complete participant protection are in place” adding “Ghana is a leader in drug regulation in Africa and we are pleased that the global community is calling on us to assist Africa in a time of great need”.
The academic and clinical research community in Ghana is being encouraged to take advantage of these studies to contribute to science. The FDA encourages all Ghanaians to visit its website (www.fdaghana.gov.gh) for more detailed information on the Ebola vaccine trials as well as other issues of importance to Ghana.
1. What are measures in place to treat the Ebola Virus disease?
No specific treatment or vaccine for the virus is currently available, although a number of potential treatments are being studied. The following basic interventions, when used early, can significantly improve the chances of survival:
• Providing intravenous fluids (IV) and balancing electrolytes (body salts).
• Maintaining oxygen status and blood pressure.
• Blood transfusions
• Treating other infections if they occur.
A number of experimental treatments are being considered for use in the context of the recent outbreak. Treatments which will prevent people from getting the disease are also undergoing experiments. These kinds of treatments are known as vaccines.
A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as a threat, destroy it, and keep a record of it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.
2. What is a clinical trial?
The experiments being conducted on the treatments and vaccines are known as clinical trials. Clinical Trials are researches that are conducted to determine whether a medicine, medical strategy, treatment, or device is safe and effective for humans. Clinical trial is defined by section 166 of the Public Health Act 2012, Act 851 as an “investigation consisting of a particular description by, or under the direction of a medical practitioner, dentist or veterinary surgeon to the patient or animal where there is evidence that a medicine, medical device or procedure or herbal medicine of that description has effects which may be beneficial to and safe to the patient or animal, and the medicine, medical device or procedure or herbal medicine is for the purpose of ascertaining beneficial or harmful effects”.
Clinical trials may be conducted on volunteers who have a disease or are healthy, depending upon the purpose of the research.
Clinical trials produce the most reliable data for justifying any health care decision. A trial is only conducted if existing evidence does not provide an answer to:
• Whether a new approach works well in people and is safe
• Which treatments or strategies work best for certain illnesses or groups of people
An Ebola Vaccine trial is therefore a clinical trial that will test the safety of experimental vaccines that may protect against the Ebola Virus Disease and determine if the vaccine induces an immune response to the virus.
Ebola Vaccine trials will therefore help determine the safest and most effective vaccine for treating or preventing EVD.
3. Which vaccines are in development?
http://www.who.int/medicines/emp_ebola_q_as/en/ provides a summary of some ongoing clinical trials for Ebola vaccines. As indicated in the table Ghana will participate in trials that will test the safety and immunogenicity of two of the vaccines that has been developed against the disease.
The vaccines that will be tested in Ghana does not treat EVD but rather prevents EVD.
4. Can the vaccine(s) cause Ebola outbreak?
No, the Ebola vaccines to be tested cannot cause disease.
The vaccines to be tested in Ghana are made using a common cold virus called an adenovirus that does not make people sick. It has a little piece of Ebola virus attached – a small part that cannot cause disease, either. In animals, such a vaccine has been shown to stimulate the body’s immune response against Ebola virus.
5. Why is Ebola trial being conducted in Ghana when the country is not affected?
Although Ghana has not yet recorded any case of EVD, Ghana is neighbours to the epidemic areas in West Africa and people living in Ghana are at risk of contracting the disease due to high passenger flow and risk of animal transmission.
Participation in the clinical trials is also the only way that can assure that people living in Ghana can benefit from the vaccines. Participation in the trials will give crucial information about whether the tested vaccines are safe, well tolerated and capable of stimulating adequate immune responses in people living in Ghana. If it works, it could help alter the dynamic of this epidemic by interrupting transmission.
Participation of Ghana in the Ebola trials will also contribute to worldwide public health.
6. Why does it seem that the Ebola Vaccine trials are being rushed?
Ebola’s infected more than 8,000 people and killed about half of them, and the World Health Organization says the true toll is likely even higher. If it is eventually shown to work and if this information can be generated fast enough, it could become a public health tool to bring the current, and future, Ebola virus disease epidemics under control.
7. Who will authorize conduct of the clinical trials in Ghana?
The Government of Ghana gives the Food and Drugs Authority (FDA) the power to authorize and monitor clinical trials in Ghana (Past 8 of the Public Health Act 2012, Act 851). The trial protocols are being reviewed for approval both the FDA and the experts from various Independent committees responsible for the ethical review of the trials. The Technical Advisory Committee on Clinical Trials is also reviewing the trial protocols and will provide expert advice for conduct of the trials when required.
8. Should the FDA give approval, will they still monitor the clinical trials?
Yes, The FDA monitors all approved trials in Ghana and especially with a sensitive clinical trial like this; the FDA has already conducted pre- trial inspection of the sites and trained the study team to ensure that both the site and personnel are all in good position for effective work as per international and national standards.
9. Can the Ebola vaccines to be tried in Ghana cause side effects in people who will be vaccinated?
Just like any vaccination, it may come with certain common side effects like fever, chills or headaches, or feel fatigue or muscle pain. These reactions usually last no longer than a few hours and disappear with medication to bring the fever down. Some volunteers may also experience joint pain, beginning in the first two weeks after vaccination and generally lasting no more than a few days.